Ignite Creation Date:
2024-05-06 @ 9:51 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03090373
Status:
UNKNOWN
Last Update Posted:
2017-03-24
First Post:
2017-03-20
Brief Title:
The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters
Sponsor:
Rosenblum Jonathan I DPM
Organization:
Rosenblum Jonathan I DPM
Study Overview
Official Title:
The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters The duration of the trial is 30 days The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group
Detailed Description:
This is a double blinded Randomized controoled trial of 30 days duration The trial device is the Uroshield SAW device which is an externally applied device attached to the external portion of the urinary catheter
Subjects will be randomized to a control group and the treatment group The control group will receive standard of care for the care of indwelling urinary catheters while being attached to a sham UroShield device The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device
At baseline and again at 30 days both the catheter and retained urine from the bladder will be evaluated for the number of live colonies These numbers will be evaluated to see if there is a difference between the active and sham devices
Subjects will be randomized to a control group and the treatment group The control group will receive standard of care for the care of indwelling urinary catheters while being attached to a sham UroShield device The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device
At baseline and again at 30 days both the catheter and retained urine from the bladder will be evaluated for the number of live colonies These numbers will be evaluated to see if there is a difference between the active and sham devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None